Indications and uses
temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever
temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever
do not take more than directed the smallest effective dose should be used swallow whole; do not crush or chew drink a full glass of water with each dose adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours children under 12 years: do not use
each caplet contains: sodium 22 mg store at 20° to 25°C (68° to 77°F) store in a dry place Meets USP dissolution test 3.
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine Hydrochloride USP 120 mg, extended-release
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Nasal decongestant
temporarily relieves these cold, sinus, and flu symptoms:
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.
call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
NDC 58602-832-83
*Compare to active
ingredients in
Aleve-D® Sinus & Headache
Naproxen Sodium and
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP
220 mg/120 mg
Non-Drowsy
THIS CARTON IS NOT CHILD RESISTANT
Pain Reliever/Fever Reducer (NSAID)
Nasal Decongestant
SINUS & HEADACHE
12 Hour Multi-Symptom Relief of
10 Caplets
(1 x 10's blister)
AUROHEALTH 1 Caplet - 12 Hours

| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1367426 | naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet | PSN | 4 |
| 1367426 | 12 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet | SCD | 4 |
| 1367426 | naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet | SY | 4 |
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-832-67 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | 4 | |
| 58602-832-67 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | 4 | |
| 58602-832-83 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 4 | |
| 58602-832-83 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58602-832 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE SINUS AND HEADACHE (NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AUROHEALTH LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250124_10a8a74b-11d1-490e-87e7-d705fe0e7602.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-832 | 58602-832-83, 58602-832-67 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 5c6f7cd8ea54… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211360-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2022-06-01 | a50c72e98297… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | Aurohealth LLC | 10a8a74b-11d1-490e-87e7-d705fe0e7602 | 2025-01-21 | Warnings | 58602-832-67 58602-832-83 58602-832 58602083267 58602083283 0287563f-3472-401d-b95f-9694258def17 10a8a74b-11d1-490e-87e7-d705fe0e7602 |
Adverse event summaries are temporarily unavailable. Other product information remains available.